Voluntary Recall Issued for Neostigmine Methylsulfate
June 29, 2018 – Fagron Sterile Services has voluntarily recalled two lots of Neostigmine Methylsulfate 5mL syringes due to a confirmed customer complaint of incorrect labeling. The affected lots contain syringes mislabeled as containing a 3mg/3mL dose rather than 5mg/5mL, which can lead to potential overdose.
According to the recall announcement, the improper administration of a 5mg/5mL dose when a 3mg/3mL dose is needed can cause severe side effects, including cardiovascular problems, paralysis, and fatal Cholinergic Crisis. Other potential side effects include but are not limited to nausea, muscle cramps, and diarrhea.
Fagron has not received any reports of adverse events or injuries as of the initial date of the recall. The affected lots are C274-000004690, expiration date September 21, 2018, and C274-000004678, expiration date September 20, 2018. NDIC numbers for these lots are 71266-2003-02 and 71266-2003-01, respectively. Fagron has asked consumers to call 1-877-405-8066 with any questions they may have regarding the recall. Adverse effects that may be related to the use of Neostigmine Methylsulfate 5mL syringes should be reported to the FDA’s MedWatch program. Additional information can be found at:
Neostigmine methylsulfate injection must be administered by a healthcare professional, and is indicated to reverse the effects of certain types of anesthesia after surgery. It is also used to prevent and treat certain postoperative kidney and intestinal issues, and to treat myasthenia gravis (weakness and rapid fatigue of skeletal muscles). The drug first received FDA approval in 1939.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.